Software Medical Device Classification
In accordance with Article 51 of the Medical Device Regulation (MDR), medical devices are categorized into four classes: I, IIA, IIb, and III. This classification process considers factors such as duration of use, invasiveness, and active device status, and is governed by 22 classification rules outlined in Annex VII of the Regulation. While these rules primarily focus on hardware devices, software is specifically addressed only in Rule 11. The following list aims to enhance understanding of Rule 11 while providing examples for each class:
Class I: All software not specifically categorized in the following classes. Example: Basic health tracking applications.
Class IIa: · Software designed to provide information for decision-making related to diagnosis or treatment, unless it falls under a more critical category. · Software intended to monitor physiological processes, except when it is for tracking vital physiological parameters that could pose immediate danger to the patient. Example: Software that provides diagnostic support for non-critical conditions.
Class IIb: · Software intended for decision-making that could lead to significant deterioration of a person’s health or require surgical intervention. · Software for monitoring vital physiological parameters where variations could result in immediate risk to the patient. Example: Software used in managing chronic conditions that require close monitoring.
Class III: · Software intended to provide information for decision-making that may result in death or irreversible harm to a person’s health. Example: Software used in life-support systems or critical care management.
In addition to Rule 11, it is essential to consider Implementing Rules 3.3 and 3.5:
Implementing rule 3.3 of Annex VIII states that software influencing a device is classified with the device, while independent software is classified separately. Medical Device Software that serves its own purpose and influences a hardware device is classified based on its intended purpose, with a minimum risk class equal to that of the hardware.
Additionally, implementing rule 3.5 mandates that the strictest applicable rule or sub-rule determines the device’s classification. While healthcare technology manufacturers must comply with these regulations, it is not surprising that most MDR-related online resources focus predominantly on hardware, leading to confusion surrounding software classification.